Experts recommend more clinical trials, preventive measures to tackle COVID-19 pandemic

Experts recommend more clinical trials, preventive measures to tackle COVID-19 pandemic

Shardul Nautiyal, Mumbai
Monday, April 20, 2020, 08:00 Hrs  [IST]

Experts have recommended that more randomized trials are needed to come out with a full-proof and efficacious therapy for COVID-19 patients. According to them, there are no specific antiviral agents available for its treatment.

One of the recent treatment trials is based on convalescent plasma (CP) transfusion to rescue end stage positive COVID-19 patients.

The Indian Council of Medical Research (ICMR) has approved trial of plasma therapy in Kerala. In Delhi, it is reported that CP has been used in two patients. The technique is to use plasma of patients who have completely recovered from COVID-19 as it is rich in antibodies.

According to Dr Narendra Saini, chairman, Scientific Committee, Delhi Medical Council (DMC), “On paper it seems good but there are no strong evidences that it always works. This technique was effective to treat hemorrhagic fever in 1979 and the Spanish influenza in 1918 and helped reduce mortality in both epidemics but not so effective for Ebola in 2014. Some small studies have been done in China and United States for COVID-19 where they had tried this treatment.”

The plasma donor has to be a person who has recovered from COVID-19 at least 2 to 3 weeks back and have significant antibody titre and two molecular negative test reports. It carries similar risks as blood transfusion such as allergic reactions or acute lung injury caused by fluid overload.

In China, clinical trials, a dose of 200 ml of CP with the neutralizing antibody titers above 1:640 was transfused to critical patient. There was improvement in clinical symptoms within 3 days. Radiological examination showed varying degrees of absorption of lung lesions within 7 days, he further added.

Sharing his perspective on the subject, Dr Nitin Malekar, geneticist and healthcare communication expert explained,” Indian researchers are not very far behind in the race to develop vaccine for COVID-19. Several companies are competing with International giants, but human trials will take some time as stringent measures are to be followed for proving the safety and efficacy of the vaccine. Immunity response of a particular population is also critical in case of diseases like COVID-19. Further genetic research needs to be conducted to check the reasons of lower impact of the disease in Indian population.”

World Health Organization (WHO) defines SARS-CoV-2 or COVID-19 as a new strain of coronavirus that has not been previously identified in humans. The virus is similar to SARS coronavirus therefore it is known as SARS coronavirus 2.

Talking about the measures to tackle COVID-19 Pharma Consultant Dr Sanjay Agrawal opines, “Sequencing of COVID-19 genome has been done in four countries – USA, Italy, China and India. What is concluded through this sequencing is that this virus has different genome in India as compared to China and Italy. Single mutation has been occurred in the spike protein which has made the attachment weak in India. Spike protein is that part which attach to the host receptor. This could be the reason why mortality is higher in other region. The lockdown will help a lot in controlling the spread of the virus and after that extensive testing should be done to detect the presence of the virus as South Korea did.”

ICMR has recently announced protocol for a multi-center, phase II, open label, randomized controlled study named Therapeutic Plasma Exchange (TPE) in COVID-19 for its therapy. The therapy is also called CP therapy which according to health experts has the potential to treat critically ill COVID-19 patients.

ICMR study will assess the efficacy of TPE in improving the clinical status of COVID-19 patients. It will also evaluate the safety of treatment with anti SARS-CoV-2 plasma in patients with COVID-19. The subjects for inclusion in the trial study are hospitalised COVID-19 patients who are critically ill, fulfill the inclusion and exclusion criteria and are admitted for care at COVID-19 management facilities in India.